JAVELIN Bladder 100: Bavencio is the first immunotherapy to significantly prolong overall survival in locally advanced or metastatic urothelial carcinoma in the first-line setting
Phase III JAVELIN Bladder 100 study met its primary endpoint of overall survival ( OS ) at the planned interim analysis. In this study, patients with previously untreated locally advanced or metastatic urothelial carcinoma ( UC ) whose disease did not progress on induction chemotherapy and who were randomized to receive first-line maintenance therapy with Avelumab ( Bavencio ) and best supportive care ( BSC ) lived significantly longer than those who received BSC only.
A statistically significant improvement in overall survival ( OS ) was demonstrated in the Avelumab arm in each of the co-primary populations: all randomized patients and patients with PD-L1–positive tumors.
The safety profile for Avelumab in the trial was consistent with that in the JAVELIN monotherapy clinical development program.
Avelumab is a human anti-programmed death ligand-1 ( PD-L1 ) antibody.
In JAVELIN Bladder 100 a total of 700 patients whose disease had not progressed after induction chemotherapy as per RECIST v1.1 were randomly assigned to receive either Avelumab plus BSC or BSC alone.
The primary endpoint was overall survival in co-primary populations of all patients and patients with PD-L1-positive tumors. Secondary endpoints include progression-free survival, anti-tumor activity, safety, pharmacokinetics, immunogenicity, predictive biomarkers and patient-reported outcomes in the co-primary populations.
In 2017, the FDA approved Bavencio for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following Platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with Platinum-containing chemotherapy.
This indication was approved under accelerated approval based on tumor response and duration of response. JAVELIN Bladder 100 is the confirmatory study for the conversion to full approval.
Urothelial carcinoma accounts for about 90% of all bladder cancer. When bladder cancer is metastatic, the five-year survival rate is 5%.
Combination chemotherapy is currently the first-line standard of care for patients with advanced disease, but despite high initial response rates, durable and complete responses following first-line chemotherapy are uncommon, and most patients will ultimately experience disease progression within nine months after initiation of treatment. ( Xagena )
Source: EMD Serono, 2020